Clinical Evaluation Of Remote Monitoring With Direct Alerts To Reduce Time From Event To Clinical Decision
NCT ID: NCT01090349
Last Updated: 2019-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2010-03-31
2014-04-30
Brief Summary
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This investigation is designed with the hypothesis that detection of events (system integrity and diagnostic related) through Direct Alerts™ via Remote Monitoring allow clinicians an earlier opportunity to address and resolve events and may therefore improve patient care.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Direct Alerts ON
Direct Alerts in implantable device were turned on
Implantation of an ICD/CRT-D device
The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation.
Merlin.NET PCN
The Merlin.Net™ PCN is a dedicated computer system that connects physicians to patients outside of the clinic setting by centralizing data from remote transmissions, implant procedures and in-clinic follow-ups into single location with easy export to Electronic Health Record (EHR) systems
Direct Alerts OFF
Direct Alerts in implantable device were turned off
Implantation of an ICD/CRT-D device
The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation.
Merlin.NET PCN
The Merlin.Net™ PCN is a dedicated computer system that connects physicians to patients outside of the clinic setting by centralizing data from remote transmissions, implant procedures and in-clinic follow-ups into single location with easy export to Electronic Health Record (EHR) systems
Interventions
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Implantation of an ICD/CRT-D device
The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation.
Merlin.NET PCN
The Merlin.Net™ PCN is a dedicated computer system that connects physicians to patients outside of the clinic setting by centralizing data from remote transmissions, implant procedures and in-clinic follow-ups into single location with easy export to Electronic Health Record (EHR) systems
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient is recently (≤2 weeks) implanted with a SJM device compatible with the Merlin.net™ PCN - (inclusive of upgrade from ICD to CRT-D or an implantable pulse generator change)
* The patient has a life expectancy of greater than 12 months (based on the physician's discretion).
* The patient is mentally capable to participate in the investigation (based on the physician's discretion).
* The patient is 18 years of age or older
Exclusion Criteria
* The patient has primary valvular disease that has not been corrected.
* The patient had a myocardial infarction within the last month
* The patient had unstable angina within the last month.
* The patient has had Coronary Artery Bypass Grafting (CABG) within the last month.
* The patient had a Percutaneous Coronary Angioplasty (PTCA) within the last month.
* The patient is pregnant.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Janet McComb, MD
Role: PRINCIPAL_INVESTIGATOR
Freeman Hospital Newcastle; UK
Locations
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Dr. Ralph Bosch
Ludwigsburg, , Germany
Freeman Hospital
Newcastle, , United Kingdom
Countries
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Other Identifiers
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CR-09-064-WW-RC
Identifier Type: -
Identifier Source: org_study_id
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